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Trial planning

Project protocol

Your project protocol is an outline of how your clinical trial will be conducted.

The project protocol is part of the trial process that compiles all relevant information so you can proceed with your research. By outlining all the details, you can ensure that your methods are safe and ethically sound for all participants. Likewise, this is an important step as you can ensure your results will be scientifically recorded and reproducible.

Here are some things to include in your project protocol: 

  • an introduction to your trial. This includes a description of the rationale supporting the trial and a list of objectives
  • a clear study design indicating whether or not it is randomised or controlled. As well as a description of the methodology
  • eligibility criteria for the inclusion and exclusion of participants
  • a detailed description of any interventions, such as mediation dosages and schedules
  • a clear method of defining outcome measures and collecting and managing data
  • a method of managing safety and reporting monitoring
  • consideration of applicable ethics and regulations
  • assurances of quality control
  • plans for sharing and publishing results
  • each of these elements compiled into a clear and concise document to complete your project protocol.

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